Sr. Specialist - Training, Quality Assurance

Posted 13 Days Ago
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Indianapolis, IN, USA
In-Office
69K-88K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Support and oversee employee training and quality assurance programs under cGMP. Develop and deliver training, maintain eLMS, author and review SOPs and quality documents, evaluate training effectiveness, assist with CAPAs/deviations, and partner with site management to resolve quality issues.
Summary Generated by Built In

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for the cGMP documentation review related to product release, material controls, laboratory controls, packaging and labeling, and production and process controls.

  • Demonstrates knowledge of quality systems and approaches and an understanding of the relevant regulation, standards, and operating procedures.

  • Assists in ensuring all aspects of employee training are kept up to date and compliant to all regulatory and quality requirements.

  • Helps oversee the employee training program, including applicable materials, procedures, and in-person/virtual training.

  • Assists in the responsibility of ensuring all quality standards and procedures are followed and projects manufactured are of the highest quality possible.

  • Authorized to inspect products to ensure quality standards are met.

  • Adheres to established policies and procedures.

  • Provides technical guidance and training to others on SOPs and quality guidelines.

Job Summary
The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (Training) in order to minimize risks, drive compliance, and adhere to regulatory requirements. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Supervisor, Quality Assurance in Training activities and develops actionable insights and recommendations for addressing complex quality issues.
Responsibilities

  • Assists in the oversite, development, and maintenance of employee training program, materials, and procedures.

  • Helps ensure all aspects of employee training are complaint to quality standards and procedures.

  • Facilitates and/or delivers in-person training, including but not limited to, new employee orientation and quality procedures/systems.

  • Effectively communicates and interacts with site personnel and management in a professional, collaborative, and respectful manner to ensure that their technical and compliance-based training requirements are met.

  • Assists in the administration and maintenance of the electronic Learning Management System (eLMS) including the creation of new training items, curriculums, and user groups.

  • Works with site management to identify training needs and in the development of training materials/curriculum.

  • Evaluates training effectiveness.

  • Keeps abreast of training and development research for new materials, methods, and techniques.

  • Champion Quality, GMP compliance and EHS/Radiation Safety practices.

  • Assist in the development and facilitation of GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements.

  • Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems, including but not limited to, employee training.

  • Authors and optimizes SOPs and other documents as necessary and performs change controls, deviations, and CAPAs as needed.

  • May assist in various Quality Assurance duties such as: change control and non-conformance processes and review/approval of quality events.

  • Ability to network across business and functional units to achieve positive outcomes.

  • Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.

  • Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.

Qualifications

  • Bachelor’s degree or previous work experience in a similar role or related field.

  • 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).

  • Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.

  • Possesses and understanding of cGMP and compliance requirements for pharmaceutical products.

  • Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.

What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks

  • Works on projects of moderate scope and complexity

  • Identifies possible solutions to a variety of technical problems and takes action to resolve

  • Applies judgment within defined parameters

  • Receives general guidance and may receive more detailed instruction on new projects

  • Work reviewed for sound reasoning and accuracy

Anticipated salary range: $68,500.00-$88,020.00

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

  • Medical, dental and vision coverage

  • Paid time off plan

  • Health savings account (HSA)

  • 401k savings plan

  • Access to wages before pay day with myFlexPay

  • Flexible spending accounts (FSAs)

  • Short- and long-term disability coverage

  • Work-Life resources

  • Paid parental leave

  • Healthy lifestyle programs

Application window anticipated to close: 10/13/2026

*if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Skills Required

  • Bachelor's degree or equivalent previous work experience in a similar role or related field.
  • Minimum 2 years relevant experience working with 21 CFR 210 and 211 in an FDA-regulated industry (pharmaceutical or medical device).
  • Experience authoring SOPs, Change Controls, CAPAs, Deviations, and Laboratory Investigations.
  • Working knowledge and understanding of cGMP and compliance requirements for pharmaceutical products.
  • Proficient in Microsoft Word and Microsoft Excel and strong technical writing skills.
  • Experience with administration and maintenance of an electronic Learning Management System (eLMS), including creating training items, curriculums, and user groups.
  • Experience delivering in-person training (new employee orientation, quality procedures) and evaluating training effectiveness.
  • Ability to support troubleshooting of quality deficiencies and implement corrective measures in partnership with site management.

Cardinal Health Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cardinal Health and has not been reviewed or approved by Cardinal Health.

  • Leave & Time Off Breadth Paid time off is frequently described as generous, including examples like multiple weeks of vacation, additional sick days, and in some roles even “unlimited” or untracked time off. Parental leave, paid holidays, and volunteer time further broaden the overall leave offering.
  • Healthcare Strength Medical, dental, and vision coverage is positioned as comprehensive, with added supports such as preventive care, telehealth/clinic access, mental health resources, and EAP counseling. Wellness programs and incentives (e.g., premium discounts tied to checkups or healthy lifestyle actions) add to the perceived breadth of healthcare-related support.
  • Retirement Support A 401(k) with company match, along with programs like stock purchase/equity participation and charitable matching, contribute to a stronger total rewards picture beyond base pay. Additional financial supports such as disability coverage and early wage access also enhance the overall package.

Cardinal Health Insights

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The Company
HQ: Dublin, OH
44,000 Employees
Year Founded: 1971

What We Do

Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. We are navigating the complexities of healthcare and providing scaled solutions to help our customers thrive in a changing world. We strive to be a trusted healthcare partner by driving growth in evolving areas of healthcare, while building upon our distribution, products, and solutions to meet customer needs.

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